Clinical Trial: Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).

Brief Summary:

On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to constitute the ACTUAA collaborative working group. The main objectives of the working group are:

To create a working basis for analyzing the diagnostic features, treatment modalities and outcomes of interest of both the antibiotic-first approach and appendectomy for patients with uncomplicated AA.

To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis To determine the outcomes of patients treated with antibiotics or appendectomy in the short and long term periods.

To compare results according to the type of intervention. To stratify the risk of recurrence for patients treated with antibiotics according to clinical, laboratory and radiology findings.

To evaluate the sensibility and specificity of clinical and laboratory scores for the diagnosis of uncomplicated AA.

To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be highly effective.

General study design The study protocol is designed according to the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials".

The study period is estimated to be of 12 month + 12 month of follow-up (with a second session of follow-up following 5-years), beginning on 01/04/2017.

Participants All adult patients (aged

Detailed Summary:
Sponsor: Mauro Podda

Current Primary Outcome: Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale. [ Time Frame: 1 year ]

Number of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course: no postoperative complications, adverse events, or treatment failure occurring, as assessed by the Dindo-Clavien Classification. Post-treatment abdominal abscess, bowel occlusion, incisional hernia, pulmonary embolism, cardio-vascular complications, surgical site infection, complications due to anesthesia, adverse reactions to antibiotics. Complications are analyzed both for patients submitted to appendectomy and for those treated with surgery as second line approach, after primary antibiotic treatment failure. For patients treated with antibiotics, treatment failure (persistency and recurrence rates of acute appendicitis) will be evaluated within the overall-complications rate. Specific sub-analyses of the complications will be carried out.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of hospital stay [ Time Frame: 1 week ]
    Length of post-operative hospital stay for patients submitted to appendectomy; length of hospital stay for patients treated with antibiotics
  • VAS-Score [ Time Frame: 1 month ]
    Pain evaluation performed through the visual analogue scale both for patients who undergo an appendectomy and for those treated with antibiotics
  • Time to return to normal activity [ Time Frame: 1 month ]
    Time to return to normal activity both for patients who undergo an appendectomy and for those treated with antibiotics
  • Period of sick-leave [ Time Frame: 1 month ]
    Period of sick-leave, intended as "absence from work"
  • Complicated appendicitis with peritonitis identified at the time of surgical operation. [ Time Frame: 1 year ]
    In the antibiotic group the analysis will be carried out within the cohort of patients who will undergo appendectomy after the failure of the antibiotic therapy in order to assess whether or not a major risk of perforated appendicitis exists for patients who will be treated firstly with antibiotics.
  • Quality of life as assessed by the Short Form 12-scale (SF-12) [ Time Frame: 1 year ]
    Quality of life estimated by the Short Form 12-scale (SF-12)


Original Secondary Outcome: Same as current

Information By: Associazione Chirurghi Ospedalieri Italiani

Dates:
Date Received: March 5, 2017
Date Started: June 1, 2017
Date Completion: December 31, 2018
Last Updated: May 1, 2017
Last Verified: May 2017